BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2123757 · Received June 14, 2011

    Report

    Report Number
    6000001-2011-07678
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEARLINK PRIMARY SET THAT WAS SET UP WITH ONE (1) SECONDARY BAXTER SET AND AN UNSPECIFIED SIGMA SPECTRUM PUMP IN WHICH THERE WAS A NO FLOW WHEN THE SECONDARY SET WAS ATTACHED TO AN UNKNOWN Y-SITE OF THE PRIMARY SET. THE MEDICATION BEING ADMINISTERED WAS AN UNKNOWN ANTIBIOTIC. THE CUSTOMER STATED THE DEFICIENCY WAS AGAINST THE PRIMARY CLEARLINK SET. THERE WAS NO ALARM FROM THE PUMP REPORTED. THIS CONDITION OCCURRED DURING AN ADMINISTRATION ON A PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER SECONDARY SET| UNKNOWN ANTIBIOTIC,SIGMA PUMP